# FDA 483 - Henke Sass Wolf Of America, Inc - September 16, 2025

Source: https://www.keypedia.com/records/483/henke-sass-wolf-of-america-inc/34862c8d-2c45-4ef2-be19-6f9a7135cfd7

> FDA 483 for Henke Sass Wolf Of America, Inc on September 16, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Henke Sass Wolf Of America, Inc
- Inspection Date: 2025-09-16
- Product Type: devices
- Summary: During a Food and Drug Administration (FDA) inspection conducted from September 10 to September 16, 2025, Henke Sass Wolf Of America, Inc., a contract manufacturer based in Dudley, Massachusetts, was issued an FDA Form 483. The inspection identified a significant deficiency related to the company's quality system requirements. Specifically, the main observation cited a lack of established procedures for acceptance activities.
The FDA noted that Henke Sass Wolf Of America, Inc. did not have a documented process to ensure that salvaged goods, derived from medical devices and subsequently placed into inventory for use in manufacturing finished devices, met the necessary specifications for each component part. An illustrative example provided by the FDA detailed a finished device that was manufactured utilizing a salvage part without any documented acceptance activities for that component. This indicates a potential risk to product quality and patient safety.
This observation highlights a need for the company to enhance its regulatory compliance framework, specifically concerning the quality system requirements under the Federal Food, Drug, and Cosmetic Act. Henke Sass Wolf Of America, Inc. is required to address this observation by establishing and implementing robust procedures for acceptance activities for all salvaged components. Furthermore, the firm is responsible for conducting internal self-audits to identify and correct all violations and is expected to provide a response outlining their corrective and preventive actions to the FDA.

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/henke-sass-wolf-of-america-inc/f5ba401d-dc6f-4f42-866e-d9da0da4ef20